Creon 25000,25000 units 20 pcs

An enzyme preparation that improves the digestive processes. Pancreatic enzymes contained in the drug facilitate the digestion of proteins, fats, carbohydrates, which leads to their complete absorption.

The drug has a specially designed dosage form – a gelatin capsule containing enteric minimicrospheres. The capsules dissolve quickly in the stomach, releasing hundreds of minicrospheres.

The purpose of the multiple-dose principle here is to mix the minicrospheres with the intestinal contents and ultimately to better distribute the enzymes within the intestinal contents once they are released.

When the minicrospheres reach the small intestine, their enteric coating breaks down, causing the release of pancreatic enzymes with lipolytic, amylolytic and proteolytic activity, resulting in the disintegration of fat, starch and lipid molecules.

Indications

Replacement therapy of pancreatic exocrine function insufficiency in the following conditions: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, pancreatic duct obstruction due to neoplasm (such as pancreatic duct or common bile duct obstruction), Schwachmann-Daimond syndrome, senile age.

For symptomatic therapy of digestive disorders in the following cases: conditions after cholecystectomy, partial gastric resection (Bilroth-1/P), total gastrectomy, duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, pathology of the terminal small intestine, excessive bacterial growth in the small intestine.

To avoid complications, use only after consulting a physician.

Active ingredient

Composition

One capsule contains:

The active ingredient:

Pancreatin 300 mg,

Associated substances:

Macrogol 4000 – 75 mg,

Hypromellose phthalate – 112.68 mg,

dimethicone 1000 – 2.69 mg,

cetyl alcohol – 2.37 mg,

triethyl citrate – 6.26 mg.

Contents of the hard gelatin capsule shell:

gelatin – 95.08 mg,

iron oxide red dye (E172) – 0.46 mg,

iron oxide yellow dye (E172) – 0.08 mg,

titanium dioxide (E171) – 0.19 mg,

sodium lauryl sulfate – 0.19 mg.

How to take, the dosage

The drug is taken orally, it is recommended to take 1/2 or 1/3 of a single dose at the beginning of meals and the rest with meals. The dose is determined individually, depending on the severity of the disease and the composition of the diet. Capsules or minimicrospheres should be swallowed whole without breaking or chewing, with plenty of water.

In case of difficulty in swallowing (e.g., in young children or elderly patients) the capsules are opened gently and the minimicrospheres are added to liquid food (pH< 5) that does not require chewing or taken with liquid (pH< 5). Any mixture of minimicrospheres with food or liquid should not be stored and should be taken immediately after preparation. It is important to ensure adequate fluid intake at all times, especially if there is increased fluid loss.

Inadequate fluid intake may lead to increased constipation Crushing or chewing the mini-crospheres or adding them to foods with a pH >5.5 will destroy their gastric juice-protective coating.

In cystic fibrosis, the starting dose of lipase for children under 4 years of age is 1000 IU of Ph. Eur./kg per meal; for children over 4 years of age, 500 IU of Ph. Eur./kg per meal.

The dose should be determined according to the severity of symptoms, results of steatorrhea control, and maintenance of good nutritional status.

In most patients, the lipase dose should not exceed 10,000 IU of Ph. Eur./kg/day.

In other conditions with exocrine pancreatic insufficiency, the dose is adjusted for the degree of digestive insufficiency and the fat content of the food.

The dose of lipase a patient requires with the main meal (breakfast, lunch, or dinner) ranges from 20,000 to 75,000 IU of Ph. Eur., with approximately 5,000 to 25,000 IU of Ph. Eur. during light meals.

Special Instructions

The drug should not be used orally in the early stages of acute pancreatitis. Children with cystic fibrosis who take Creon® 25 000 for a long time should be regularly monitored by a specialist.

In patients with cystic fibrosis who have received high-dose pancreatin preparations, strictures of the ileum and cecum and colitis have been described. In case-control studies, there was no evidence of an association between the occurrence of fibrosing colonopathy and the administration of Creon®.

As a precautionary measure to rule out colonic involvement, all unusual symptoms or abdominal changes should be monitored – especially if the patient is taking (per lipase) more than 10,000 IU of Ph. Eur./kg body weight/day.

The use of Creon® is allowed in patients who are practicing Muslim and Judaizers. Effect on the ability to drive and operate machinery The drug has no effect on the ability to drive and operate machinery.

Synopsis

Contraindications

Side effects

When evaluating the data obtained in clinical trials, the overall incidence of adverse reactions associated with the use of pancreatin was similar to that of placebo.

Digestive system disorders: often – abdominal pain; in some cases – constipation, stool changes, diarrhea, nausea, vomiting.

Allergic reactions: in some cases – skin manifestations, hypersensitivity reactions.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Pregnancy use

The use of Creon® during pregnancy and lactation (breastfeeding) is possible only if the expected beneficial effects of therapy for the mother outweigh the possible risk for the fetus or child, due to the lack of reliable clinical data confirming the safety of pancreatic enzymes in this category of patients.

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